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Completed

NCT Number: NCT02035735

Interest of Narrow Band Imaging in Detection of Upper Aerodigestive Cancers

The aim of this study is to prospectively determine if the use of NBI endoscopy modifies the superficial extension of these tumors.

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Key information

About this study

Several studies have already showed the interest of the use of NBI for the early diagnosis of malignancies of the upper aerodigestive tract. For all tumors, the most accurate evaluation of its limits is very important to perform the best strategy of treatment. If surgery seems to be the best option, surgical margins must be widely healthy. Despite the systematic transnasal flexible endoscopy with white lamp followed by laryngoscopy under general anesthesia (LGA) and tomodensitometric evaluation, surgical margins can be unhealthy (in situ carcinoma or dysplasia). We propose to evaluate if the use of the NBI could be useful to determine the superficial spread of squamous cell carcinomas in these locations.

To April 2013 to Mars 2015, all patients with a suspicion of squamous cell carcinoma of the oropharynx, hypopharynx or larynx and whom a LGA are expected, are included. The day before the LGA, two endoscopies by two different physicians were performed for each patients and recorded: the first one with white light and the second one with NBI. All results are noted on a schema. Superficial extension or synchronous lesions showed by NBI are analysed and compared with with lamp technic.

After surgery, surgical margins were evaluated and healthy margins were measured.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients who can benefit a laryngoscopic exam under general anesthesia

Exclusion criteria

  • General anesthesia contra-indications
  • Local anesthesia allergy
  • Breast-feeding period or pregnancy

Treatment and study plan

WL and NBI

Procedure

For each patient with a suspicion of squamous cell carcinoma of the oropharynx, hypopharynx or larynx for whom a laryngoscopy under general anesthesia (LGA) is expected benefit the day before a transnasal endoscopy with white lamp (WL) and NBI by two different operators. Suspected mucosal abnormalities showed by one or the two technics are reported in a table wich describes the different areas of the pharynx and the larynx. During the LGA, several biopsies are performed and identified (WL and/or NBI).

Primary outcomes

  1. Number of patients for whom superficial extension of the tumors has been increased by NBI.

    Time frame: 4 minutes

Secondary outcomes

  1. Number of tumors upstaged.

    Time frame: 4 minutes

  2. Contribution of the NBI in the diagnosis of other synchronous locations.

    Time frame: 4 minutes

  3. Contribution of the NBI in the diagnosis of pre-neoplastic lesions.

    Time frame: 4 minutes

  4. Contribution of the NBI in the evaluation of surgical margins.

    Time frame: 4 minutes

Sponsors and collaborators

Lead sponsor

University Hospital, Toulouse

Other

Registry information

Official study title

Usefulness of Narrow-band Imaging to Estimate the Superficial Spread of Squamous Cell Carcinomas in Oropharynx, Hypopharynx and Larynx

Important dates

Study start
2014
Primary completion
2017
Study completion
2017
First posted
Jan 14, 2014
Registry last updated
Dec 11, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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